Lax system means killer drugs slip through

Australia has no early warning system to detect the harm that
drugs such as Vioxx could do to an unsuspecting public, say experts
who predict more people will die needlessly from adverse reactions
to medication.

Even well-run, randomised trials examining a drug's safety and
effectiveness could not pick up the long-term harm it could cause
in a much larger population, said Fiona Stanley, the director of
the Telethon Institute for Child Health Research at the University
of Western Australia.

Only that state had a sophisticated system that linked
depersonalised information from the Medical and Pharmaceutical
Benefits Scheme with the health outcomes of a population, said
Professor Stanley, who is a former Australian of the Year.

That way, the impact of a drug such as Vioxx, which is thought
to increase the risk of strokes and heart attacks, could be
measured by looking at both prescribing levels and the incidence of
cardiovascular disease.

"If we had this capacity in Australia we could have picked this
up more quickly and avoided so many deaths," she said.

Vioxx was just one example of the harm prescription drugs could
cause, Professor Stanley said.

The anti-inflammatory drug was withdrawn from the market by its
manufacturer, Merck & Co, on September 30 last year because of
evidence it increased the risk of cardiovascular disease.

At the time 250,000 to 300,000 Australians were taking the drug
to treat the symptoms of arthritis; there are concerns up to 300
people may have died because of the drug's side-effects.

As further concerns emerged about the safety of the entire Cox-2
Inhibitor class of drugs, the limitations of the Therapeutic Goods
Administration came into sharp focus.

"These questions are not easily addressed by just doing another
clinical trial," said David Henry, a professor of public health at
the University of Newcastle.

"The TGA should have the capacity of rapid response to urgently
commission studies to investigate this safety issue ..."

But Professor Henry, a specialist in clinical pharmacology, said
Australia had fallen way behind other countries in this area, and
the TGA this week complained that it lacked the power to order a
large-scale study.

Meanwhile, an Australian law firm confirmed it was close to
making a decision on whether to pursue a class action against Merck
on behalf of more than 300 people who suffered heart attacks or
strokes from Vioxx.

Despite clear signs in March 2000 that taking the drug increased
the risk of cardiovascular disease, Merck failed to warn doctors or
patients for another two years, said Richard Meeran, of Slater
& Gordon.

However, a spokeswoman for Merck said the first indication the
company had of an increased risk of cardiovascular disease was just
before it voluntarily withdrew Vioxx on September 30 last year.

James Parry, 64, of Quakers Hill, had a massive heart attack in
June last year after taking Vioxx for about two years to cope with
arthritis. "There was nothing wrong with me before I started taking
those tablets," he said, confirming he is one of the those involved
in the possible class action.